Statements (58)
| Predicate | Object |
|---|---|
| gptkbp:instance_of |
gptkb:Clinical_Trials
|
| gptkbp:advocacy |
informed consent obtained
|
| gptkbp:analysis |
statistical analysis plan
|
| gptkbp:blinding_method |
double-blind
|
| gptkbp:clinical_trial |
improvement in quality of life
|
| gptkbp:collaboration |
with dermatology specialists
|
| gptkbp:collaborator |
various research institutions
|
| gptkbp:collection |
patient-reported outcomes
|
| gptkbp:condition |
psoriasis
|
| gptkbp:criteria |
history of certain infections
history of inadequate response to systemic therapy |
| gptkbp:data_monitoring |
conducted regularly
|
| gptkbp:duration |
16 weeks
|
| gptkbp:eligibility |
adults with moderate to severe plaque psoriasis
|
| gptkbp:follow-up_duration |
up to 52 weeks
|
| gptkbp:funding |
provided by Abb Vie
|
| gptkbp:future_prospects |
potential for further studies on long-term effects
|
| gptkbp:has_implications_for |
impact on psoriasis treatment guidelines
|
| https://www.w3.org/2000/01/rdf-schema#label |
UNCOVER-1
|
| gptkbp:identifier |
NCT02684344
|
| gptkbp:investigational_phase |
clinical development phase
|
| gptkbp:is_located_in |
various clinical sites
|
| gptkbp:is_studied_in |
randomized, double-blind, placebo-controlled
|
| gptkbp:is_tested_for |
Phase 3
|
| gptkbp:location |
multiple countries
|
| gptkbp:long-term_safety |
assessed in extension studies
|
| gptkbp:outcome_reporting |
transparent and accurate
|
| gptkbp:participants |
approximately 2000
Dermatology Life Quality Index (DLQI) Psoriasis Area and Severity Index (PASI) score |
| gptkbp:patient_population |
diverse population
|
| gptkbp:prevention |
gptkb:risankizumab
|
| gptkbp:primary_investigator |
lead researcher name
|
| gptkbp:provides_information_on |
available upon request
|
| gptkbp:publication |
results published in medical journals
|
| gptkbp:randomization_method |
computer-generated random numbers
|
| gptkbp:recruitment |
through multiple channels
|
| gptkbp:regulatory_compliance |
FDA approved
|
| gptkbp:related_products |
risankizumab (ABBV-181)
|
| gptkbp:research_areas |
dermatology
|
| gptkbp:research_focus |
treatment of psoriasis
|
| gptkbp:research_output |
demonstrated significant improvement in skin clearance
|
| gptkbp:result |
positive efficacy
|
| gptkbp:safety_features |
generally well-tolerated
|
| gptkbp:side_effect |
monitored throughout the study
|
| gptkbp:sponsor |
gptkb:Abb_Vie
|
| gptkbp:start_date |
2016-01-01
|
| gptkbp:study_completion_status |
completed
|
| gptkbp:study_endpoints |
primary and secondary endpoints defined
|
| gptkbp:study_oversight |
monitored by independent committees
|
| gptkbp:study_protocol |
adhered to regulatory guidelines
|
| gptkbp:study_results_publication |
published in peer-reviewed journals
|
| gptkbp:study_results_summary |
summarized in clinical trial reports
|
| gptkbp:trial_registry |
gptkb:Clinical_Trials.gov
|
| gptkbp:year |
2018-12-31
|
| gptkbp:bfsParent |
gptkb:ixekizumab
gptkb:Ixekizumab |
| gptkbp:bfsLayer |
6
|